Skin angiosarcoma Trials in Disease

Study of Trabectedin alone versus Trabectedin with tTF-NGR combination therapy in adults with metastatic or refractory soft tissue sarcoma who failed first-line treatment

This clinical trial is investigating treatment options for patients with advanced soft tissue sarcoma, including angiosarcoma, whose cancer has either spread to other parts of the body or has not responded to previous treatments. The study is being conducted in Germany and will continue until March 2029.

Main focus and goal: The trial compares two different treatment approaches to determine which is more effective at keeping the cancer under control. One group of patients receives only trabectedin, a chemotherapy medication that interferes with cancer cell growth. The other group receives trabectedin combined with tTF-NGR, an experimental drug designed to help trap the chemotherapy inside the tumor, potentially making the treatment more effective. Both medications are given through intravenous infusion directly into the bloodstream, and treatment can continue for up to 360 days.

Investigational drugs: The study uses trabectedin, a cancer medication that works by interfering with cancer cell growth and division, typically used when other treatments have not been effective. The experimental component is tTF-NGR, a protein that targets blood vessels in tumors and is intended to help concentrate the chemotherapy medication where it is needed most. This combination approach aims to improve treatment effectiveness by keeping the medication concentrated inside the tumor.

Who can participate (inclusion criteria): The study is open to adults between 18 and 75 years of age who have been diagnosed with advanced or metastatic soft tissue sarcoma, including several specific types such as angiosarcoma. Participants must have high-grade cancer that either did not respond to previous treatment with anthracycline medications or cannot take these medications due to medical reasons. An important requirement is that the tumor must test positive for a specific protein marker called CD13. Participants must have at least one measurable tumor that has not been treated with radiation, a life expectancy of at least 3 months, and be able to carry out daily activities. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 3 months afterward. Men must use birth control methods for 5 months after the last treatment.

Who cannot participate (exclusion criteria): The trial excludes people outside the age range of 18 to 75 years, those without a confirmed diagnosis of soft tissue sarcoma, and anyone who has not received previous treatment with anthracycline therapy. Patients whose tumors test negative for the CD13 protein marker are not eligible. The study also excludes pregnant or breastfeeding women, those without measurable disease, and anyone who has previously been treated with trabectedin. People with severe heart, liver, or kidney problems, active uncontrolled infections, other active cancers requiring treatment, or known allergies to the study medications cannot participate. Those unable to provide informed consent or who have participated in another clinical trial within the past 30 days are also excluded.

Summary

Currently, there is one active clinical trial available for patients with skin angiosarcoma, located in Germany. This trial is part of a larger study investigating treatment for various types of soft tissue sarcomas. The study focuses on patients whose cancer has progressed or not responded to initial treatments, comparing standard chemotherapy with a novel combination approach. The trial requires specific tumor characteristics, particularly CD13 positivity, which must be confirmed through laboratory testing before enrollment. This research represents an important step in exploring new treatment strategies for patients with advanced angiosarcoma and related soft tissue sarcomas who have limited treatment options after first-line therapy fails.